KEM Hospital Research Centre, Pune

K.E.M Hospital, Pune celebrated its diamond jubilee in 1972. At that time a need was felt to further improve and expand their services.Read Further

Surgery

MLN0002- "Protocol C13008: A Phase 3, open-lable study to determine the long term safety and efficacy of SMLN0002 in patients with Ulcerative Colitis and Crohn's Disease.
Research Studies/Trials Undertaken
PI
Dr. B G Kalambe
Sub -I 
Dr. Aniket Zarkar & Dr. Mayur Gangawal
CRC
Ms. Deepa Patil
Sponsor
Millenium Pharmaceuticals Inc. USA
CRO
Quiltiles Rsearch (India) Provate Limited, Mumbai, India
Period of study
Mar 2009 to 2016
 Objective : To determine the safety profile of long-term MLN0002 treatment
MLN0002 is a humanized monoclonal antibody that binds to the α4β7 integrin, which is expressed on discrete populations of leukocytes involved in gut mucosal immunity.

 

Protocol No. D4280C00001: A Phase III, randomized, multicenter, double-blind, double-dummy, parallel-group, comparative study to determine the efficacy, safety, and tolerability of Ceftazidime Avibactam (CAZ-AVI) Plus Metronidazole versus Meropenem in the treatment of Complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
 
PI Dr. B G Kalambe
Co-PI Dr. Vinod Naik
Sub-I
Dr. Aniket Zarkar & Dr. Mukund Chaudhari (blinded team)
Dr.Mayur Gangwal & Dr.Dhiraj Chavan (Unblinded team)
CRC Ms. Deepa Patil
Sponsor AstraZeneca
CRO P P D pharmaceuticals  development (India) private Limited
Period of study September 2012 to Aug 2014
 
Objective : To assess the noninferiority of CAZ-AVI plus Metronidazole compared to Meropenem with respect to clinical cure at the test of cure visit in patients who have at least one identified pathogen.